Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203341

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BOSULIF (BOSUTINIB MONOHYDRATE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: BOSUTINIB MONOHYDRATE
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203341
Product Number: 001
Approval Date: Sep 4, 2012
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

BOSULIF (BOSUTINIB MONOHYDRATE)
EQ 400MG BASE
Marketing Status: Prescription

Active Ingredient: BOSUTINIB MONOHYDRATE
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203341
Product Number: 003
Approval Date: Oct 27, 2017
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

BOSULIF (BOSUTINIB MONOHYDRATE)
EQ 500MG BASE
Marketing Status: Prescription

Active Ingredient: BOSUTINIB MONOHYDRATE
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203341
Product Number: 002
Approval Date: Sep 4, 2012
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information